Actively Recruiting
Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-08-14
246
Participants Needed
31
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study adopted a randomized, open-label, positive drug-controlled, multi-center trial design. The primary endpoint was PFS evaluated by the Independent Review Committee (IRC). Eligible subjects were randomly assigned in a 1:1 ratio to receive either TQB2102 for injection or trastuzumab emtansine for injection.
CONDITIONS
Official Title
Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agreed to participate and signed informed consent with good compliance
- Age between 18 and 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival longer than 3 months
- HER2-positive unresectable, locally advanced or metastatic invasive breast cancer confirmed by histopathology or cytology
- HER2 positive defined as immunohistochemical 3+ or FISH dual probe positive per 2018 ASCO/CAP guidelines
- Hormone receptor status determined; HR positive means ER and/or PR positive with ≥1% tumor cell staining per 2020 ASCO/CAP guidelines
- Prior treatment with anti-HER2 monoclonal antibody and taxane drugs during recurrence/metastasis
- Disease progression during or after most recent treatment or intolerance to it
- Received at least one line of treatment in recurrence/metastasis stage
- At least one measurable lesion as per RECIST 1.1 criteria
You will not qualify if you...
- Known spinal cord compression or active central nervous system metastases
- Only skin and/or intracranial lesions as target lesions
- Unresolved adverse reactions from previous treatments with CTCAE grade >1
- Poorly controlled hypertension (systolic ≥150 mmHg or diastolic ≥100 mmHg)
- Major cardiovascular diseases
- History or current interstitial lung disease/pneumonia requiring steroid treatment or suspected by screening imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
The First Affiliated Hospital of Anhui Medical University
Bengbu, Anhui, China, 233099
Not Yet Recruiting
2
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230000
Actively Recruiting
3
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
Not Yet Recruiting
4
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Not Yet Recruiting
5
Beijing Shunyi Hospital
Beijing, Beijing Municipality, China, 101300
Not Yet Recruiting
6
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350000
Not Yet Recruiting
7
The First Hospital Of Lanzhou University
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
8
Jiangmen Central Hospital
Jiangmen, Guangdong, China, 529000
Not Yet Recruiting
9
Affiliated Cancer Hospital Of Guangxi Medical University
Nanning, Guangxi, China, 530028
Not Yet Recruiting
10
Cancer Hospital Of Guizhou Medical University
Guiyang, Guizhou, China, 550001
Not Yet Recruiting
11
Hainan General Hospital
Haikou, Hainan, China, 570311
Not Yet Recruiting
12
The Fourth Hospital Of Hebei Medical University
Shijiazhuang, Hebei, China, 050035
Not Yet Recruiting
13
Affiliated Cancer Hospital Of Harbin Medical University
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
14
Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital)
Jiamusi, Heilongjiang, China, 154007
Not Yet Recruiting
15
Anyang Cancer Hospital
Anyang, Henan, China, 455001
Not Yet Recruiting
16
The First Affiliated Hospital Of Henan University Of Science & Technology
Luoyang, Henan, China, 471000
Not Yet Recruiting
17
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
18
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Not Yet Recruiting
19
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, China, 024000
Not Yet Recruiting
20
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Not Yet Recruiting
21
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
Not Yet Recruiting
22
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Not Yet Recruiting
23
The Second Hospital Of Dalian Medical University
Dalian, Liaoning, China, 116000
Not Yet Recruiting
24
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China, 110041
Not Yet Recruiting
25
Affiliated Hospital Of Jining Medical University
Jining, Shandong, China, 272029
Not Yet Recruiting
26
Linyi Cancer Hospital
Linyi, Shandong, China, 276000
Not Yet Recruiting
27
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 201321
Not Yet Recruiting
28
Dazhopu Central Hospital
Dazhou, Sichuan, China, 635000
Not Yet Recruiting
29
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China, 637000
Not Yet Recruiting
30
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
31
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China, 310002
Not Yet Recruiting
Research Team
Z
Zhimin Shao, Doctor
CONTACT
J
Jin Zhang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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